A Phase 1 Study of KHK4083 in Healthy Volunteers and Subjects With Ulcerative Colitis

A Phase 1, Single-Blind, Randomized, Placebo-Controlled, Single-Dose or Open-Label Multiple-Dose Study of KHK4083 in Healthy Adults and Subjects With Ulcerative Colitis

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02985593

Enrollment

155

Registered

2016-12-07

Start date

2016-12-31

Completion date

2017-12-26

Last updated

2023-08-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy Men and Subjects With Ulcerative Colitis

Brief summary

The objectives of this study are to evaluate the safety and tolerability of a single intravenous (IV) or subcutaneous (SC) dose of KHK4083 in Japanese or White healthy men in a placebo-controlled, single-blind comparative study, and to evaluate the safety and tolerability of multiple IV doses of KHK4083 in subjects with ulcerative colitis in an open-label study.

Interventions

DRUGKHK4083

DRUGPlacebo

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

ALL

Age

20 Years to No maximum

Healthy volunteers

Yes

Inclusion criteria

Part1: Inclusion Criteria: 1. Voluntary written informed consent to participate in the study; 2. Japanese or White men ≥20 and \<45 years at the time of informed consent;

Exclusion criteria

1. Current illness requiring treatment; 2. Current respiratory, gastric, renal, or liver disease; Part2: Inclusion Criteria: 1. Voluntary written informed consent to participate in the study; 2. Men or women ≥20 years of age at the time of informed consent; 3. Ulcerative colitis diagnosed ≥6 months prior to informed consent; 4. Moderate or more severe ulcerative colitis;

Design outcomes

Primary

Measure	Time frame
Incidence of treatment-emergent adverse events (TEAEs) or drug-related TEAEs and their nature	Part1: Up to 18 weeks post drug administration, Part2: Up to 22 weeks post drug administration

Secondary

Measure	Time frame
Serum KHK4083 concentration	Part1: Up to 18 weeks post drug administration, Part2: Up to 22 weeks post drug administration
Maximum concentration (Cmax) of KHK4083	Part1: Up to 18 weeks post drug administration, Part2: Up to 22 weeks post drug administration
Time to reach Cmax (tmax) of KHK4083	Part1: Up to 18 weeks post drug administration, Part2: Up to 22 weeks post drug administration
Area under the curve (AUC) of KHK4083	Part1: Up to 18 weeks post drug administration, Part2: Up to 22 weeks post drug administration
Anti-KHK4083 antibody production	art1: Up to 18 weeks post drug administration, Part2: Up to 22 weeks post drug administration

Countries

Japan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026